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CTRI Number  CTRI/2025/01/079300 [Registered on: 23/01/2025] Trial Registered Prospectively
Last Modified On: 17/01/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Other (Specify) [premature oral motor intervention]  
Study Design  Other 
Public Title of Study   A study to compare the effectiveness of Premature Infant Oral Motor Intervention versus routine care on oral feeding readiness among preterm neonates  
Scientific Title of Study   Effectiveness of Premature Infant Oral Motor Intervention on oral feeding readiness among preterm neonates-A randomized controlled trial  
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
Not applicable  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Meenu Chandran J 
Designation  PG Nursing student  
Affiliation  Government College of Nursing Thiruvananthapuram 
Address  Government College of Nursing Thiruvananthapuram Child Health Nursing Department Kerala

Thiruvananthapuram
KERALA
695011
India 
Phone  6238970159  
Fax    
Email  meenuchandranmjm@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Meenu Chandran J 
Designation  PG Nursing student  
Affiliation  Government College of Nursing Thiruvananthapuram 
Address  Government College of Nursing Thiruvananthapuram Child Health Nursing Department Kerala

Thiruvananthapuram
KERALA
695011
India 
Phone  6238970159  
Fax    
Email  meenuchandranmjm@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Sreeja SA 
Designation  Assistant Professor 
Affiliation  Government College of Nursing Thiruvananthapuram 
Address  Government College of Nursing Thiruvananthapuram Pediatric Nursing Department Kerala

Thiruvananthapuram
KERALA
695011
India 
Phone  8547475708  
Fax    
Email  sreejaajith@gmail.com  
 
Source of Monetary or Material Support  
Not applicable 
 
Primary Sponsor  
Name  Meenu Chandran J 
Address  Government College of Nursing Thiruvananthapuram Kerala 695011 
Type of Sponsor  Other [self] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Dr Sreeja S A  Government Medical college HOSPITAL THIRUVANANTHAPURAM   Neonatal intensive care unit
Thiruvananthapuram
KERALA 
6238970159

sreejagajith@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee government college of nursing medical college Thiruvananthapuram constituted as per order no.A4/1579/2011/CNT dtd 21/7/2011   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: R69||Illness, unspecified,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Premature Infant Oral Motor Intervention   Efficacy of Premature Infant Oral Motor Intervention on Oral feeding readiness among preterm neonates Duration of intervention 3 times per day total 14 days  
Comparator Agent  Routine care given to the control group  Compare the effectiveness of premature infant oral motor intervention versus routine oral massage on oral feeding readiness among preterm infants Duration 14 days 
 
Inclusion Criteria  
Age From  7.00 Month(s)
Age To  8.00 Month(s)
Gender  Both 
Details  Preterm neonates born between 29 to 32 weeks of gestation
Preterm neonates who are haemodynamically stable
 
 
ExclusionCriteria 
Details  Neuromuscular disorder
Chromosomal anomaly
Craniofacial malformmation
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To determine the efficacy of Premature Infant Oral Motor Intervention on oral feeding readiness among preterm neonates 
The outcome will be assessed 7th and 14th day of the study 
 
Secondary Outcome  
Outcome  TimePoints 
Not applicable  Not applicable 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" 
Phase of Trial   N/A 
Date of First Enrollment (India)   01/03/2025 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   N/A 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary  

Title

Efficacy of Premature Infant Oral Motor Intervention on Oral feeding readiness among preterm neonates – A randomized controlled trial

Objective of the study

=  To determine the efficacy of Premature Infant Oral Motor Intervention (PIOMI) on oral feeding readiness among preterm neonates admitted in Neonatal Intensive Care Unit.

FoFormal permission for data collection will be obtained from Institutional Research Committee, Institutional Ethics committee, Medical Superintendent SAT Hospital Thiruvananthapuram and Head of the department, Neonatology. After getting informed consent from the parents investigator will select preterm neonates admitted in NICU who meet the eligibility criteria for the study and will be randomly allocated in to experimental and control group. The samples will be allocated equally by using block randomization with fixed block size of 4 in to two groups, experimental and control group. The preterm neonates in the experimental group will receive PIOMI for 15 minutes before the gavage feed, along with the routine nursing care 2 times daily using aseptic precautions. This process will be continued for maximum 14 days, when the baby reaches feeding readiness whichever is earlier. The control group will also receive routine care during the 14 days of the study. Both groups will be assessed from the 4th day onwards till the achievement of oral feeding readiness. (POFRAS score >30)





 
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